Misoprostol as a treatment for miscarriage instead of surgery

A drug first used to reduce the risk of stomach ulcers
in people taking certain types of painkillers offers
an alternative to surgery after miscarriage, according
to a study by researchers at the National Institute
of Child Health and Human Development of the National
Institutes of Health and other research institutions.

The study appears in the August 18, 2005, New England
Journal of Medicine.

The drug, misoprostol, has been used to reduce the
risk of stomach ulcers that occur in people who take
certain pain relievers for arthritis. Misoprostol is
now more commonly used to induce labor, as it stimulates
contractions of the uterus.

In recent years, physicians have begun prescribing
misoprostol in place of surgery to women who have experienced
a miscarriage. Until the current study, however, no
large-scale studies have been undertaken to evaluate
the safety and effectiveness of the drug in treating
miscarriage.

This is the first comprehensive study to show that
misoprostol is an effective alternative to surgery in
the treatment of miscarriage, said Duane Alexander,
M.D., Director of the NICHD. Unlike conventional surgery,
which is usually conducted in an operating room, treatment
with misoprostol can be done on an out-patient basis.

The study authors wrote that pregnancy failure, or
miscarriage, occurs in 15 percent of pregnancies. With
miscarriage, in some cases, a fetus dies in the womb,
explained the studys first author, Jun Zhang, M.D.,
Ph.D., an investigator in the Epidemiology Branch of
NICHDs Division of Epidemiology, Statistics, and Prevention
Research. In other cases, a fetus may no longer be present,
and women may carry a placenta and sac of amniotic fluid.

In all of these cases, the standard treatment is a
surgical procedure known as vacuum aspiration. In this
procedure, the cervix is dilated, and a suction device
is used to remove the uterine contents. As an alternative,
women and their doctors may choose to wait for the uterus
to expel the tissue without additional medical treatment.
Such expulsion is by no means certain, and may take
more than a month. Many women, grieving from the failed
pregnancy, may prefer not to wait. Occasionally, the
uterus may fail to expel the remaining fetal tissue,
and in some of these cases, the uterus may become infected.

Within the last few years, physicians have used misoprostol
to treat pregnancy failure, and some researchers have
conducted a few small studies of the drugs effectiveness
in treating that condition. However, no definitive evidence
existed to determine whether the drug was safe and effective
enough for routine medical practice.

For the current study, Dr. Zhang and colleagues at
several institutions enrolled 652 women who experienced
pregnancy failure. Of these, 491 were assigned at random
to receive misoprostol. The rest of the women underwent
vacuum aspiration. The women in the misoprostol group
were treated with 4 vaginal doses of misoprostol, each
containing 200 mcg. of the drug. If the uterus had not
expelled its contents by the end of three days, the
women received a second misoprostol treatment. If, after
5 more days had passed, the uterine contents still had
not been expelled, the women were offered vacuum aspiration.

By the end of the third day, 71 percent of the women
receiving misoprostol experienced complete uterine expulsion.
After 5 more days had passed, a total of 84 percent
of the misoprostol group had complete uterine expulsion.
The misoprostol treatment failed for 16 percent of the
group, however. In contrast, 3 percent of the vacuum
aspiration group experienced treatment failure, and
needed to undergo the procedure a second time. Complications
from either misoprostol or vacuum aspiration — uterine
hemorrhage and infection of the uterine lining — were
rare, occurring in less than 1 percent of each group.

Of the women in the misoprostol group, 78 percent said
they would choose the drug again if they needed to,
and 83 percent said they would recommend it to other
women.

Dr. Zhang noted that, because misoprostol causes uterine
contractions, treatment with the drug could bring about
abdominal pain and cramping. The researchers treated
minor pain caused by the treatment with ibuprofen and
treated more intense pain with codeine.

He added that the misoprostol treatment provided an
effective alternative for women who preferred to avoid
the surgical procedure. Moreover, because it could be
performed on an out-patient basis, the misoprostol treatment
was less expensive and could provide women more privacy
and convenience than vacuum aspiration. Roughly one
in four women experience miscarriage, so the availability
of a non-surgical treatment may provide an effective
alternative for many women, he added.

Misoprostol is inexpensive and does not need to be
refrigerated, Dr. Zhang said. It could provide treatment
for miscarriage in developing countries where safe surgical
treatment may not be readily accessible.

Other authors of the study were Jerry M. Gilles, M.D.,
the University of Miami, Florida; Kurt Barnhart, MD,
MSCE, the University of Pennsylvania, Philadelphia;
Mitchell D. Creinin, M.D., the University of Pittsburgh;
Carolyn Westhoff, M.D., Columbia University, New York;
and Margaret M. Frederick, Ph.D., Clinical Trials and
Surveys Corporation, Baltimore, M.D.

The NICHD is part of the National Institutes of
Health (NIH), the biomedical research arm of the federal
government. NIH is an agency of the U.S. Department
of Health and Human Services. The NICHD sponsors research
on development, before and after birth; maternal,
child, and family health; reproductive biology and
population issues; and medical rehabilitation.

The National Institutes of Health (NIH) — The
Nation’s Medical Research Agency — is comprised
of 27 Institutes and Centers and is a component of
the U. S. Department of Health and Human Services.
It is the primary Federal agency for conducting and
supporting basic, clinical, and translational medical
research, and investigates the causes, treatments,
and cures for both common and rare diseases. For more
information about NIH and its programs, visit http://www.nih.gov.